FDA adverse event reporting form to include question as to third-party service

By Robert J. Kerwin Medical device manufacturers, importers, distributors and user facilities have long been required to report deaths, serious injuries and malfunctions that have, may have or would be likely to cause or contribute to a death or serious injury. The FDA regulation pertaining to "user facilities" provides that reports should be filed on [...]

By |2020-10-02T12:49:18+00:00October 2nd, 2020|Government, Healthcare|0 Comments

First federal ‘right to repair’ legislation filed in US to help hospitals through pandemic

An opinion piece by Robert J. Kerwin Senator Ron Wyden (D-Ore) and Rep. Yvette Clark (D-NY) filed today in the U.S. Senate and the U.S. House of Representatives the first federal right to repair legislation. “There is no excuse for leaving hospitals and patients stranded without necessary equipment during the most widespread pandemic to hit [...]

By |2020-08-10T16:14:06+00:00August 10th, 2020|Government, Healthcare|0 Comments

HSCC Legacy Medical Device Task Group Aims to Mitigate Cyber Threats

May 13, 2020 By Robert J. Kerwin This article is reprinted with permission of DOTmed HealthCare Business News and can be read online in its original format at: https://www.dotmed.com/news/story/51199  In April, the FBI reported a global increase in malicious cyberactivity targeting U.S. Healthcare providers, noting that the cyberactivity was exploiting fear derived from the COVID-19 [...]

By |2020-05-14T16:45:54+00:00May 14th, 2020|Government, Healthcare|0 Comments

IAMERS CONTINUES TO ADVOCATE AS THE FDA SERVICING DEBATE RAGES ON DESPITE THE FDA REPORT RECOMMENDING NO NEW REGULATIONS

With rumors of a possible renewed push for Congressional legislation, IAMERS president Diana Upton and general counsel Robert Kerwin attended the AAMI Annual Meeting during the first week of June 2018. Their attendance is  part of IAMERS’ efforts to reduce the fear-mongering and  to get out the message of independent servicers for safe patient oriented [...]

By |2018-06-08T12:21:42+00:00June 8th, 2018|Government, Healthcare|0 Comments

Congress delays medical device tax for two years

WASHINGTON — Almost no one got everything they wanted out of the Monday deal to reopen the government — except perhaps medical device companies, who managed to fend off an industry-wide excise tax before the first payments were due.   The stopgap spending deal that was signed by President Trump on Monday included a two-year delay of the 2.3 percent [...]

By |2018-01-25T10:18:12+00:00January 25th, 2018|Business, Government|0 Comments

The Joint Commission Introduces New Element of Performance — Service Manuals

George Mills, Director of Engineering for the accrediting organization, The Joint Commission, announced yesterday at the American College of Clinical Engineers (ACCE) meeting a new element of performance expected which essentially requires healthcare organizations to have on hand  service manuals and technical bulletins: EP 3 provides "The organization has a library of information regarding inspection, [...]

By |2017-06-10T13:25:06+00:00June 10th, 2017|Business, Government|0 Comments

Servicing Legislation Update

On June 7, 2017, the U.S. House of Representatives Energy and Commerce Committee approved an amendment to the FDA Reauthorization Act of 2017 which will require the FDA to submit to the House and Senate Committees  a report on how the FDA intends to ensure the quality and continued effectiveness of devices with respect to [...]

By |2017-06-08T13:51:21+00:00June 8th, 2017|Government, Regulatory|0 Comments
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